NCT02502019

HEMOBLAST Pilot Clinical Investigation

Prospective, Multicenter, Single-arm Pilot Clinical Investigation Evaluating the Use of a Surface Bleeding Severity Scale (SBSS) and the Safety and Efficacy of a New Hemostatic Device in Abdominal and Orthopedic Lower Extremity Surgeries

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Biom'Up France SAS · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.

Detailed description

HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical. This is a prospective, multicenter, single-arm pilot clinical investigation. There will be 36 subjects enrolled across 4 investigational sites. The subjects will be followed at hospital charge and 6 weeks postoperatively. The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators. Secondary endpoints of this clinical investigation consist of: * Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application; * Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application; * Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application; and * Incidence of adverse events through final follow-up.

Conditions

• Hemostasis

Interventions

Type	Name	Description
DEVICE	HEMOBLAST Bellows	HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-07-17
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

3 sites across 1 country: United States